Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

InVitro Diagnostics

About IVD

  1. In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules

    • The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.

  1. In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:

    • Low risk - Class A;

    • Low moderate risk- Class B;

    • Moderate high risk- Class C;

    • High risk- Class D.

  1. Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.

  2. The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:

    • Import of all Classes of In Vitro Diagnostic Medical Device

    • Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices

    • Clinical Performance evaluation and approval of new in vitro diagnostic medical devices 

    • Co-ordination with the State Licensing Authorities

  3. The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-

    • Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices

    • Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.

Functionalities

  1. Grant of Import Licence: The applicant shall make an application in MD-14 in sugam online portal for grant of import licence in MD-15 to import In Vitro Diagnostic Medical Devices.

  2. Grant of licence or loan licence to manufacture for sale or for distribution: The applicant shall make an application in MD-7 & MD-8 in sugam online portal for Grant of manufacturing Licence / Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.

  3. Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-12 in sugam online portal for licence in MD-13 to manufacture In Vitro Diagnostic Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

  4. Grant of test licence to import for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-16 in sugam online portal for licence in MD-17 to import In Vitro Diagnostic Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

  5. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device: The applicant shall make an application in in MD-24 in sugam online portal for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in MD-25.

  6. Permission to import or manufacture new in vitro diagnostic medical device: The applicant shall make an application in MD-28 in sugam online portal for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-29.

  7. Registration of medical device testing laboratory: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (IVDMD) testing laboratory for test or evaluation on behalf of manufacturer.

  8. Preparation of Guidance and FAQ on key activities.

  9. Processing of application for Issuance of Free Sale Certificate for domestic manufacturers In Vitro Diagnostic Medical Devices.

  10. Complaint, NSQ Verification.

  11. Updating the list as per the Classification of IVD Medical Devices from time to time.

  12. Post Approval Changes in respect of In-Vitro Diagnostic Medical Devices.

  13. Constitution of IVD exerts committee.

  14. Inspection of manufacturing site for compliance of QMS by CLA/SLA.

  15. Capacity building activities of technical management.

  16. Registration of notified bodies for audit of Class A and Class B.

Processes

Organogram

New image

Guideline

image Guidelines Document

Approved Data

Archived Documents

S.no Title Release Date Download Pdf Pdf Size
1 IN-VITRO DIAGNOSTIC ALERT FOR PRODUCT " BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube 2018-Mar-03 196 KB
2 In-VitroDdiagnostic alert for product " BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube" 2018-Jan-01 196kb
3 IVD Diagnostic Kit Alert for Comipack ABD 2018-Jan-01 74kb
4 IVD Diagnostic Kit Alert for Mediclone D 2018-Jan-01 144kb
5 Medical Device Adverse Event reporting form 2017-Jan-01 1,655kb
S.no Title Release Date Download File link Pdf Size
1 Brief note on Two Days workshop on Medical Devices Framework organized by Danish Medical Agency (DKMA)- CDSCO on 8-9 April 2026 2026-Jun-09 Download File 304 KB
2 Launch of MedTech Mitra's In-Vitro Diagnostic Innovators Handbook 2025-Dec-23 Download File 396 KB
3 Short video of the event: Launch of MedTech Mitra's In-Vitro Diagnostic Innovators Handbook 2025-Dec-23 Download File 9854 KB
4 Global first initiative and release of compendium of standard In-Vitro Diagnostics (IVDs) Evaluation protocol and minimum standard for high risk infectious disease IVDs and launch of IVD kit validation portal 2025-Sep-18 Download File 354 KB
5 Short video of the event: Global first initiative and release of compendium of standard In-Vitro Diagnostics (IVDs) Evaluation protocol and minimum standard for high risk infectious disease IVDs and launch of IVD kit validation portal 2025-Sep-18 Download File 8939 KB
6 Applicability of IS/ISO 15197 2013 version regarding glucometer test strips 2018-May-17 Download File 249 KB
7 List of Diagnostic Kits for Blood Bank 2017-Feb-17 Download File 326 KB
8 USE OF RAPID TEST KITS FOR TESTING OF HIV AND HCV IN BLOOD BANKS (IVD's) 2017-Feb-17 Download File 467 KB
9 CLARIFICATION ISSUED BY CDSCO ON IVD (IVD's) 2017-Feb-17 Download File 210 KB
10 CLARIFICATION REGARDING NOC FOR IMPORTS OF DIAGNOSTIC KITS / REAGENTS (IVD's) 2017-Feb-17 Download File 235 KB
11 DIAGNOSTIC KIT ( REGISTRATION CERTIFICATE) (IVD's) 2017-Feb-17 Download File 135 KB
12 Guidance Document on Common Submission Format for Import of Non-Notified Diagnostic Kits in India (IVD's) 2017-Feb-17 Download File 611 KB
13 Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Diagnostic Kits in India (IVD's) 2017-Feb-17 Download File 977 KB
14 Minutes of the Meeting of the Experts Committee to Examine the Specification and Criteria for Acceptance for Test Performed on ' Syphilis Rapid and Elisa Kits' 2017-Feb-17 Download File 2028 KB
15 TEST LICENSE (IVD's) 2017-Feb-17 Download File 103 KB
16 USE OF DIAGNOSTIC KITS OF HBsAg, HIV AND HCV IN BLOOD BANKS OR PATHOLOGICAL LABS (IVD's) 2017-Feb-17 Download File 313 KB
17 DIAGNOSTIC KIT (IMPORT LICENSE) (IVD's) 2016-Feb-17 Download File 105 KB
18 DRAFT SCHEDULE M IV (IVD's) 2015-Feb-17 Download File 2007 KB
19 Guidance Document on Common Submission Format for Import of Notified Diagnostic Kits in India (IVD's) 2015-Feb-16 Download File 592 KB
20 Minutes of Meeting of IVD Industry Held on 07-08-2012 at CDSCO(HQ), New Delhi 2012-Feb-17 Download File 266 KB
S.no Title Release Date Download Pdf Pdf Size
1 Inviting comments on standard IVD evaluation draft protocols Scrub Typhus drafted by ICMR and CDSCO 2026-Jul-13 1.90MB
2 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29/06/2026 2026-Jun-29 661 KB
3 Addendum to Doc No. CDSCO. IVD. FAQ. 04. 2022 dated 13.03.2026 2026-Mar-13 321 KB
4 Provision for Risk Classification of In-Vitro Diagnostic Medical Devices on the CDSCO Online System for Medical Devices 2026-Feb-06 132 KB
5 Draft Guidance document for Import of In-vitro diagnostic Medical device for stakeholders comment (dated 30.01.2026) 2026-Feb-02 2163 KB
6 CDSCO updated list of Laboratories for conducting Performance Evaluation of In-Vitro Diagnostic Medical Device 2026-Jan-19 608 KB
7 MedTech Mitra's In-Vitro Diagnostic Innovators Handbook 2025-Dec-05 5974 KB
8 The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded in 2025 2025-Oct-22 367 KB
9 ICMR-CDSCO Standard Performance Evaluation Protocols 2025-Sep-17 7383 KB
10 Separate provision for subsequent Importer in Online system for Medical Devices 2025-Sep-15 477 KB
11 Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO 2025-Aug-26 5218 KB
12 Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 3 2025-Aug-12 4130 KB
13 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 04.06.2025 2025-Jun-04 617 KB
14 Provision for system auto-generated Neutral Code by the manufacturer for the export purpose under Medical Devices Rules 2017 2025-Apr-09 404 KB
15 Provision for auto-generated Market Standing Certificate and Non-Conviction Certificate for licenced medical device 2025-Apr-09 307 KB
16 Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form 2025-Feb-17 325 KB
17 Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 2 2025-Jan-29 1704 KB
18 Guidance document Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) 2025-Jan-16 2642 KB
19 Circular- Testing and evaluaion of Medical Devices In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country 2024-May-29 429 KB
20 Circular-Retention of license or certificates under Medical Devices Rules, 2017 2024-May-15 207 KB
21 Launching of National Single Window System (NSWS) Portal 2024-Jan-01 3669 KB
22 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23 2023-Dec-06 654 KB
23 Updation of classification in IVD medical devices under the provision of MD Rules 2017 2023-Oct-25 1473 KB
24 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 26.09.2023 2023-Sep-29 654 KB
25 CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device 2023-May-22 214 KB
26 List of Notified Bodies registered with CDSCO under MDR, 2017 2023-Apr-03 830 KB
27 Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer 2022-Dec-22 412 KB
28 Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022 2022-Oct-21 290 KB
29 Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 781 KB
30 Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 594 KB
31 Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 702 KB
32 List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software 2022-May-05 103 KB
33 Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit 2022-May-05 208 KB
34 Classification in IVD medical devices under the provision of MD Rules 2017 2021-Jul-23 45667 KB
35 Supply of essential In-Vitro Diagnostic testing reagents / kits for inflammatory markers such as IL-6 (Interleukin 6), D-Dimer and C-reactive protein (CRP) 2021-Apr-29 968 KB
36 Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits 2021-Mar-22 586 KB
37 Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021 2020-Dec-28 334 KB
38 Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices 2020-Sep-03 301 KB
39 Requirement of fees for change in address of authorized agent without change in constitution as post approval Change under MDR 2017 2020-Aug-31 362 KB
40 Clarification regarding import of diagnostic kits reagents for Research use only ROU for academic research purpose 2020-Jun-19 368 KB
41 GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS 2020-Jun-04 2174 KB
42 Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) 2020-Feb-24 849 KB
43 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
44 Expansion of testing of IVDs for Clinical Chemistry reagents/Kits at NIB Noida under the provision of Medical Device Rules 2017 2019-Oct-07 995 KB
45 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-04 2653 KB
46 Constitution of Medical Devices Technical advisory group (MDTAG) to advise CDSCO on matter related to regulation of medical devices-Reg 2019-Jul-22 650 KB
47 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
48 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
49 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
50 Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017 2018-Mar-01 638KB
51 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
52 Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices 2017-Oct-31 666 KB
53 NOTICE regarding not of Standard Quality of Mediclone D 2017-Sep-15 60 KB
54 NOTICE regarding Not of Standard Quality Combipack ABD 2017-Sep-15 73 KB
55 corrigendum with respect to revised specification criteria of acceptance for quality test for Ant-HCV Rapid Kit 2017-Jul-12 42 KB
56 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
57 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
58 NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi 2017-Apr-24 38 KB
59 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
60 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
61 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
62 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
63 Letter to All state, UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue 2015-Feb-14 295 KB
64 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
65 IVD Office Order 2014-Jun-24 1436 KB
66 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
67 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
68 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
69 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
70 Testing of Biochemical kits for estimation of glucose 2010-Aug-26 133 KB
S.no Title Release Date Download Pdf Pdf Size
1 S.O. 5980(E) dated 03.12.2018 2018-Dec-03 279 KB
2 S.O. 1352(E) dated 23.03.2018_G.S.R. 1074(E) dated 30.10.2018 2018-Oct-30 445 KB
3 G.S.R. 729 (E) dated 01.08.2018 2018-Aug-01 1742 KB
4 S.O. 3400(E) dated 11.07.2018 2018-Jul-11 2089 KB
5 S.O. 2237(E) dated 01.06.2018 2018-Jun-01 1752 KB
6 GSR 600 (E) Drugs [IVD's] 2017-Feb-17 1336 KB
7 TB Sero Notification [IVD's 2017-Feb-17 136 KB
8 G.S.R. 103(E) dated 02.02.2017 2017-Feb-02 1121 KB
9 G.S.R. 78(E) dated 31.01.2017 2017-Jan-31 3029 KB
10 G.S.R. 908 (E) dated 22.12.2014 2014-Dec-22 138 KB
11 GSR 433 (E) dated 7.June 2012 2012-Jun-07 136 KB